Last updated: 11/07/2018 01:42:37
Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Double Dummy, Active Comparator, Parallel Group, Multicenter Study to Evaluate the Safety of Once-Daily Fluticasone Furoate/GW642444 Inhalation Powder for 52 Weeks in Adolescent and Adult Subjects with Asthma
Trial description: The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants with any adverse event (AE) or serious adverse event (SAE) during the Treatment Period
Timeframe: From the start of study medication until Visit 11 (Week 52)/Early Withdrawal
Number of participants with severe asthma exacerbations during the Treatment Period
Timeframe: From the start of study medication until Visit 11 (Week 52)/Early Withdrawal
Change from Baseline in albumin and total protein at Week 12, Week 28, and Week 52/Early Withdrawal
Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
Change from Baseline in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase (CK), and gamma glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal
Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
Change from Baseline in direct bilirubin, indirect bilirubin, total bilirubin, and creatinine at Week 12, Week 28, and Week 52/Early Withdrawal
Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
Change from Baseline in chloride, carbon dioxide content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal
Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
Change from Baseline in the percentage of basophils, eosinophils, hematocrit, lymphocytes, monocytes, and segmented neutrophils in the blood at Week 12, Week 28, and Week 52/Early Withdrawal
Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
Change from Baseline in eosinophil count, total absolute neutrophil count (ANC), platelet count, and white blood cell (WBC) count at Week 12, Week 28, and Week 52/Early Withdrawal
Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
Change from Baseline in hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal
Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
Change from Baseline in hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal
Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
Number of participants with the indicated shift from Baseline to high, normal or no change, and low post-Baseline values for urinary cortisol excretion
Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
Ratio of 24-hour urinary cortisol excretion at Week 12 to Baseline
Timeframe: Baseline and Week 12
Ratio of 24-hour urinary cortisol excretion at Week 28 to Baseline
Timeframe: Baseline and Week 28
Ratio of 24-hour urinary cortisol excretion at Week 52 to Baseline
Timeframe: Baseline and Week 52
Number of participants with evidence of oral candidiasis at any time post-Baseline
Timeframe: From Baseline until Visit 11/Early Withdrawal (52 weeks)
Maximum change from Baseline in systolic blood pressure (SBP) and minimum change from Baseline in diastolic blood pressure (DBP)
Timeframe: From Baseline until Visit 11/Early Withdrawal (52 weeks)
Maximum change from Baseline in pulse rate
Timeframe: From Baseline until Visit 11/Early Withdrawal (52 weeks)
Number of participants with the indicated change from Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52
Timeframe: Baseline; Week 28, and Week 52
Number of participants with the indicated change from Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52
Timeframe: Baseline; Week 28 and Week 52
Change from Baseline in horizontal cup-to-disc ratio at Week 28 and Week 52
Timeframe: Baseline; Week 28 and Week 52
Number of participants with the indicated change from Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52
Timeframe: Baseline; Week 28 and Week 52
Change from Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52
Timeframe: Baseline; Week 28 and Week 52
Change from Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52
Timeframe: Baseline; Week 28 and Week 52
Change from Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity at Week 28 and Week 52
Timeframe: Baseline; Week 28 and Week 52
Maximum change from Baseline in the QT interval using Bazett’s correction (QTcB) and QT interval using Fridericia’s correction (QTcF)
Timeframe: Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal
Mean 24 hour Holter heart rate for participants with at least 16 hours of recorded data
Timeframe: 0-24 hours at Screening, Day 1, Week 28, and Week 52
Maximum 24 hour Holter heart rate for participants with at least 16 hours of recorded data
Timeframe: 0-24 hours at Screening, Day 1, Week 28, and Week 52
Secondary outcomes:
Not applicable
Interventions:
Drug: Fluticasone Furoate/GW642444
Drug: Fluticasone propionate
Enrollment:
503
Observational study model:
Not applicable
Primary completion date:
2011-12-05
Time perspective:
Not applicable
Clinical publications:
Busse WW, O’Byrne PM, Bleecker ER, Lötvall J, Woodcock A, Andersen L, Hicks W, Crawford J, Jacques L, Apoux L, Bateman ED. Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the beta2 agonist vilanterol administered once daily for 52 weeks in patients >=12 years old with asthma: a randomised trial. Thorax. 2013;68(6):513-20.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, vilanterol
Collaborators
Not applicable
Study date(s)
October 2009 to May 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Clinical diagnosis of asthma
- Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
- History of life threatening asthma
- Respiratory infection or oral candidiasis
Inclusion and exclusion criteria
Inclusion criteria:
- Clinical diagnosis of asthma
- Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
- FEV1 greater than or equal to fifty percent of predicted
- Currently using moderate to high dose inhaled corticosteroid therapy
Exclusion criteria:
- History of life threatening asthma
- Respiratory infection or oral candidiasis
- Asthma exacerbation
- Uncontrolled disease or clinical abnormality
- Allergies
- Taking another investigational medication or prohibited medication
Trial location(s)
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
Status
Study Complete
Location
GSK Investigational Site
Skillman, New Jersey, United States, 08558
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68123-4303
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Stockton, California, United States, 95207
Status
Study Complete
Location
GSK Investigational Site
Bad Woerrishofen, Bayern, Germany, 86825
Status
Study Complete
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Reinfeld, Schleswig-Holstein, Germany, 23858
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-12-05
Actual study completion date
2011-12-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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